Pertussis immunization: results of new trials.
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Child, Preschool↗
Biomedical subjects
A E Tozzi
Publications and source records attributed to A E Tozzi.
Incidence of invasive Haemophilus influenzae type b disease in Italian children.
To estimate the incidence of Haemophilus influenzae type b (Hib) invasive disease in Italian infants we performed a prospective study in a cohort of newborns enrolled for a randomized trial on safety and efficacy of three pertussis vaccines and followed for onset of serious disease or pertussis. The overall cumulative incidence observed in 15,601 children was 51.3/100,000 for all invasive Hib infections and 38.4/100,000 for Hib meningitis, over 27 months of observation. The incidence density of all invasive Hib disease was 28.7/100,000 person-years, while meningitis occurred with an incidence of 21.5/100,000 person-years. Among the eight cases detected, six were meningitis, one sepsis, and one cellulitis. The child with sepsis died. The incidence and epidemiology of invasive Hib disease in Italy are comparable to those reported from other European countries. Cost-benefit analyses are needed for planning Italian vaccination policy.
Cohort Studies↗
Hypotonic hyporesponsive episodes in eight pertussis vaccine studies.
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Blood Pressure↗
Common side effects in the Italian and Stockholm I trials.
We have compared the frequency of common side effects observed following vaccination in the Italian and Stockholm I Trials. A higher proportion of DTPwc vaccinees in the two trials experienced side effects compared with DTaP and DT vaccinees. Fever, local redness and tenderness were more frequently observed in all study groups in the Stockholm I Trial when compared to the Italian Trial. Despite the similarities in study design, parental recall bias, site of injection, simultaneous administration of other vaccines, and antipyretic use could have played a role in the differences observed.
Diphtheria Toxoid↗
A controlled trial of two acellular vaccines and one whole-cell vaccine against pertussis. Progetto Pertosse Working Group.
BACKGROUND: Concern about both safety and efficacy has made the use of whole-cell pertussis vaccines controversial. In some European countries, including Italy, the rate of vaccination against pertussis is low. METHODS: We conducted a double-blind trial in Italy in which infants were randomly assigned to vaccination at two, four, and six months of age with an acellular pertussis vaccine together with diphtheria and tetanus toxoids (DTP); a DTP vaccine containing whole-cell pertussis (manufactured by Connaught Laboratories); or diphtheria and tetanus toxoids without pertussis (DT). The acellular DTP vaccine was either one containing filamentous hemagglutinin, pertactin, and pertussis toxin inactivated with formalin and glutaraldehyde (SmithKline Beecham) or one with filamentous hemagglutinin, pertactin, and genetically detoxified pertussis toxin (Chiron Biocine). Pertussis was defined as 21 days or more of paroxysmal cough, with infection confirmed by culture or serologic testing. RESULTS: The efficacy of each vaccine, given in three doses, against pertussis was determined for 14,751 children over an average of 17 months, with cases included in the analysis if cough began 30 days or more after the completion of immunization. For both of the acellular DTP vaccines, the efficacy was 84 percent (95 percent confidence intervals, 76 to 89 percent for Biocine DTP and 76 to 90 percent for SmithKline DTP), whereas the efficacy of the whole-cell DTP vaccine was only 36 percent (95 percent confidence interval, 14 to 52 percent). The antibody responses were greater to the acellular vaccines than to the whole-cell vaccine. Local and systemic adverse events were significantly more frequent after the administration of the whole-cell vaccine. For the acellular vaccines, the frequency of adverse events was similar to that in the control (DT) group. CONCLUSIONS: The two acellular DTP vaccines we studied were safe, immunogenic, and efficacious against pertussis, whereas the efficacy of the whole-cell DTP vaccine was unexpectedly low.
Antibodies, Bacterial↗
Predicting the accrual rate in a vaccine clinical trial: an a posteriori evaluation of the feasibility study.
To estimate the expected accrual rate in a double blinded controlled randomized trial of the absolute clinical efficacy of three anti-pertussis vaccines in infants, we performed a series of surveys among mothers and physicians in the areas to be considered for participation in the trial. In this paper, we compared the predicted enrollment with the actual enrollment achieved at the end of the recruitment phase of the trial. The predicted enrollment rate was 27%, while the observed rate was 26%. Results from the feasibility study were highly predictive of actual enrollment rate. In the local health units (USL) where such assessments were carried out, the accrual rate, was higher than those not participating in the feasibility phase.
Adult↗
Impact of modification of diagnostic techniques and criteria on the presentation of celiac disease in the last 16 years. Observation in Rome.
Age of diagnosis and clinical pattern were studied in 97 celiac patients, diagnosed with jejunal biopsy, between 1976-1991. They were selected on the basis of clinical and laboratory patterns. The laboratory tests utilized were steatorrhea and xylose in the first years, while in recent years AGA, ARA and AEA were also utilized. The patients were divided into two groups, based on the year of first biopsy. The first group includes 36 cases diagnosed between 1976-1985, the second one 61 cases diagnosed between 1986-1991. In recent years an increase in the number of cases has been observed in our centre, particularly in patients over 2 years of age, while the number of diagnoses in children under 2 years of age was essentially the same. So-called typical symptoms prevailed in the first group, while so-called atypical symptoms are more frequent in the second. If an increase of incidence of celiac disease within the population is confirmed, a mass screening will be necessary in order to identify the atypical forms, utilizing laboratory tests, for the purpose of selecting patients to be subjected to an intestinal biopsy.
Adolescent↗
Detection of serum antibodies to the lipopolysaccharide of Escherichia coli O103 in patients with hemolytic-uremic syndrome.
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Antibodies, Bacterial↗
[To what extent is breast feeding practiced in Italy today?].
OBJECTIVES: During a survey regarding infant health in 7 regions, diffusion and length of time of breast-feeding nowadays in Italy were studied. MATERIALS AND METHODS: By OMS Epi methodology, 210 children sampled from each area of study and specialized health workers carried out the interviews at home using a specific questionnaire. The mothers were questioned about the length of time they breast fed their child. RESULTS: 76% of mothers said they breastfed, 32% said they did it for less than 3 months and 44% for more. In each area, the percentage of breastfeeding was 70% or more. This percentage changed only if the birth weight was very low or the mothers' instruction was high, but this is probably because the most cultured mothers answered easier they breast fed longer. DISCUSSION: It seems that mothers are pro-breastfeeding and, in each region, just a quarter of them don't practise it. Besides, about half women breastfed for more than 3 months. This study doesn't permit us to know why some women don't breastfeed or why they wean their children too early. For this reason, we need to curry out further studies.
Adolescent↗
A community outbreak of haemolytic-uraemic syndrome in children occurring in a large area of northern Italy over a period of several months.
From March to October 1993, 15 cases of haemolytic-uraemic syndrome (HUS) in children were detected in a large area of northern Italy, where only 8 cases had occurred in the previous 5 years. Analysis of stool and serum specimens obtained from 14 cases showed evidence of Verotoxin-producing Escherichia coli (VTEC) infection in 13. Serum antibodies to the E. coli O157 lipopolysaccharide (LPS) were found in 8 patients and to the O111 LPS in 2. An O86 VTEC was isolated from another patient. Fourteen children needed dialysis, and 1 died. No obvious epidemiologic link was observed among cases, most of whom lived in small townships. A case-control study did not show an association between HUS and food or exposure to cattle, but suggested an association with contact with chicken coops (OR = 6.5, 95% C.I. 1.2-34.9). However, VTEC were not isolated from stool samples obtained from the chicken coops involved. The risk factors for VTEC infection related to living in rural settlements, including the exposure to live poultry, should be considered in outbreak investigations.
Animals↗
Transverse limb reduction defects after chorion villus sampling: a retrospective cohort study. GIDEF--Gruppo Italiano Diagnosi Embrio-Fetali.
A retrospective cohort study was performed in five Italian obstetrical centres from 1984 to 1991 in order to verify the association between chorionic villus sampling (CVS) and transverse limb reduction defects (TLRDs). TLRD rates by period of gestation at CVS were calculated, and the study's results were compared with data from the general population. Of the 3430 pregnancies for which CVS was performed, 2759 had a known outcome. The overall rate for TLRDs was 1 in 1143 CVS pregnancies, four times higher than that of the general population in Italy (1 in 4458). The rate of TLRDs was 2.9/1000 for CVS performed at 9 weeks' gestation and 1.0/1000 for CVS at 10 weeks' gestation. A scalp defect was detected in a pregnancy in which CVS was performed at 10 weeks. A high proportion of pregnancies lost to follow-up and the poor quality of the data may have affected the results. Nevertheless, our results suggest an association between CVS carried out at less than 10 weeks' gestation and TLRDs which is consistent with the findings of other studies. CVS should not be prepared at less than 10 weeks' gestation until additional evidence is obtained.
Chorionic Villi Sampling↗
Limb anomalies following chorionic villus sampling: a registry based case-control study.
Using data from the Italian Multicentric Birth Defect Registry a case-control study was performed to verify if chorionic villus sampling (CVS) was associated with transverse limb defects (TLD), with or without features of oro-mandibular-limb hypogenesis complex (OMLHC), in the exposed offspring. The results show that the risk of TLD and OMLHC is increased following CVS, and is particularly high for CVS performed early in pregnancy, i.e., under 70 days of gestational age. These results, together with a review of other epidemiologic studies, biological data and clinical reports, strongly suggest a causative role of CVS as a risk factor for TLD and indicate that at this stage CVS before 70 days of gestational age should be discouraged as an option for prenatal diagnosis and that all patients wishing to undergo CVS should be informed about the possible risk of the procedure.
Abnormalities, Multiple↗
HIV-1 transmission through breast-milk: appraisal of risk according to duration of feeding.
OBJECTIVES: To estimate the risk of HIV-1 transmission through breast-milk in children born to infected mothers, and to determine the relationship between duration of breast-feeding and risk. DESIGN AND METHODS: The study population included 168 breast-fed and 793 bottle-fed children born to seropositive mothers. All subjects were enrolled and followed-up in the Italian Register for HIV Infection in Children; HIV sero-status was defined in all children. Multivariate analysis was performed using a logistic regression model. Independent variables included biological factors (duration of breast-feeding, gestational age, clinical condition of mother at delivery, mode of delivery, birth-weight and sex). Year of birth and age when HIV infection was diagnosed were also considered in the analysis attempting to control for possible selection biases. RESULTS: Breast-feeding increased the risk of HIV-1 transmission. The estimated adjusted odds ratio for 1 day of breast- versus bottle-feeding was 1.19 (95% confidence interval, 1.10-1.28). The infection odds ratio of breast- versus bottle-feeding increased with the natural logarithm of the duration of practice. CONCLUSIONS: These results are the first to provide an appraisal of the additional risk of HIV-1 transmission associated with a seropositive mother breast-feeding her child. Biological significance of this route of transmission was supported by demonstration of a relationship between duration of breast-feeding and risk of HIV-1 transmission.
Breast Feeding↗
Epidemiology of pertussis in a developed country with low vaccination coverage: the Italian experience.
In Italy pertussis vaccination is optional. Fewer than 40% of children younger than 5 years of age are vaccinated, and pertussis remains a common childhood disease. We use data from a variety of sources to examine trends and characteristics of Italian children with pertussis and reasons behind the low vaccine coverage. Approximately 25% of Italian children have experienced clinical pertussis by their fifth birthday. The disease is most severe in those less than 1 year of age; in this group an estimated 1 in 14 cases are hospitalized and 1 in 850 die. The incidence appears to be increasing in the 1- to 4-year age group despite increased vaccination coverage. The low vaccine coverage appears to be caused by the ambivalence of the Italian pediatric community about the vaccine rather than parental concerns about vaccine safety. Legislation is being considered to make pertussis vaccination mandatory.
Child↗
Effectiveness of an intervention program in reducing postoperative infections. Italian PRINOS Study Group.
From 1987 to 1989, the National Health Institute carried out a before and after intervention study in order to evaluate the effectiveness of active surveillance and of modification of patient care practices in reducing the incidence of postoperative infections. The initial study population consisted of 20 general and thoracic surgical wards in 12 hospitals; 11 wards were not able to complete the study and were therefore excluded from the analysis. In December 1988, after a 13-month period in which baseline infection rates were assessed in 4,096 patients, written protocols regarding modification of patient care practices were defined and applied. Effectiveness of intervention was evaluated comparing infection rates measured in a 6-month period in 1989 on 1,638 operated patients with those of the previous period. In the overall population, a reduction of 19% of nosocomial infections was observed after the intervention. When individual infection sites were considered, pneumonia rates were statistically significantly reduced by 39%; for the other infection sites the observed differences were not significant. Effectiveness of intervention varied by subgroups of wards. In three of the studied wards, surgical wound infections were significantly reduced by 72%, whereas in the remaining wards the intervention seemed to have no positive impact on infection rates. Nevertheless, the intervention seemed to have been effective in increasing the awareness of infection problems in two other wards. Results of the study suggest that a consistent reduction of postoperative infections can be achieved in surgical wards where usual patient-care practices differ from standard of patient care policies. Nevertheless, the observed variation in effectiveness of intervention by individual wards suggests that differences in structural and behavioral characteristics can affect the compliance with recommended standards.
Anti-Bacterial Agents↗
AIDS cases in adolescents and young adults in Italy: inferences from descriptive epidemiology.
To assess the magnitude of the AIDS epidemic in the Italian adolescent (13-19 years) and young adult (20-24 years) age groups, data on AIDS cases notified to the AIDS Operational Centre as of 31 March 1990 were used. Of the 6068 reported AIDS cases, 0.7% occurred among adolescents and 15.7% among young adults. Among adolescents most cases were haemophiliacs (45.4%), while among young adults, drug use was the most frequently reported mode of transmission (87.5%). Females were more likely than males to contract the disease through the heterosexual contact in both the adolescent (20.0% vs 0%) and in young adult (15.1% vs 0.7%) age groups. Among young adults a geographical trend was present with a decrease in case rates from north to south, while for adolescents the rates were higher in northern and southern than in central Italy. If the incidence of AIDS is to be reduced in Italy, further efforts should be made to target the adolescent age group, since many of the young adult cases are likely to have resulted from HIV infection during adolescence.
Acquired Immunodeficiency Syndrome↗
Does breast-feeding delay progression to AIDS in HIV-infected children?
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Acquired Immunodeficiency Syndrome↗
Unchanging clinical picture of coeliac disease presentation in Campania, Italy.
Four hundred and sixty-three new diagnoses of coeliac disease in children were made during 1973 to 1986 in our department. The distribution of new diagnoses per year did not show any decreasing trend in the period 1973 to 1986. No changing trend in breast feeding attitudes was found in the region during the same period. Analysis of the clinical pattern showed a constant distribution of age at diagnosis, onset of first symptoms and nature of symptoms throughout the period studied. These data suggest that coeliac disease is predominantly genetically determined and its expression is modulated by individual and environmental factors. The stability of the observed prevalence of the disease is parallel to the unchanging pattern of breast feeding attitudes in the region.
Adolescent↗